Preterm BirthNCT00340002
Fetal Anatomy by Three-Dimensional Ultrasound
An observational study of Preterm Birth and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Pregnancy, Fetal Growth Abnormalities
- How many people
- 3,650 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 1997to 18 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women attending Detroit Medical Center prenatal clinics in Detroit.
Who may be able to join
- All pregnant subjects will be recruited under informed consent at either Hutzel or William Beaumont Hospitals.
- The study population for both arms of this protocol will involve pregnant women greater than or equal to 15 years.
- CROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:
- 3DUS STUDIES:
- No fetal anomalies suspected by 2DUS.
- Excellent visualization of normal fetal anatomy by 2DUS.
Show all 19Show fewer
- Accurate dating criteria by 1st trimester scan and/or menstrual history.
- FETAL MRI STUDIES:
- Gestational age between 18-42 menstrual weeks.
- No known fetal abnormalities.
- CROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:
- 3DUS STUDIES:
- Congenital anomaly suspected by 2DUS.
- Accurate dating criteria by 1st trimester scan and/or menstrual history.
- FETAL MRI STUDIES:
- Gestational age between 18-42 menstrual weeks.
- Suspected fetal abnormalities.
- POSTMORTEM STUDIES:
- Suspected fetal abnormalities by prenatal ultrasound.
Who cannot join
- CROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:
- 3DUS STUDIES:
- Poor visualization of the fetus due to technical factors (e.g. obesity, surgical scar).
- History of noncompliance with prenatal visits with the current or prior pregnancy.
- FETAL MRI STUDIES:
- Inability of the patient to fit in bore of MRI system.
Show all 19Show fewer
- Metallic implants that would increase risk to patient.
- Previous occupational exposure to metal shop.
- History of claustrophobia.
- CROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:
- 3DUS STUDIES:
- Poor fetal visualization from technical factors (e.g. obesity or decreased amniotic fluid).
- FETAL MRI STUDIES:
- Inability of the patient to fit in bore of MRI system.
- Metallic implants that would increase risk to patient.
- Previous occupational exposure to metal shop.
- History of claustrophobia.
- POSTMORTEM STUDIES:
- Refusal to sign informed consent for postmortem imaging studies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hutzel Women's Hospital
Detroit, Michigan, 48201
William Beaumont Hospital
Royal Oak, Michigan
About this study
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy.
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 1,400 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography.
All cases will be placed into a digital image database. For each anomaly category, volume reconstructions will be compared to normal anatomy at specific gestational ages. Key diagnostic findings will be documented and correlated with postnatal outcome. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.
Read the detailed description
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy.
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 7,000 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. A subset of the fetuses enrolled in this protocol will also be examined by Magnetic Resonance Imaging (MRI) to identify potential advantages and limitations of this imaging modality when compared to 3DUS for the diagnosis of congenital anomalies. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography.
All cases will be placed into a digital image database. For each anomaly category, volume data will be acquired at specific gestational ages. Key diagnostic features will be documented and correlated with postnatal outcome. Postnatal correlative studies may include ultrasound, MRI, X-ray, computerized tomography (CT), and photography. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.
- Conditions
- Preterm Birth, Pregnancy, Fetal Growth Abnormalities
- Keywords
- Fetal Anatomy, Pregnancy, Prenatal Diagnosis, Natural History
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women aged 18 years and older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Anatomy
Data analysis is ongoing
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start26 Nov 1997
- Primary completion18 Nov 2016
- Study completion18 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roberto Romero, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340002
- Sponsor's protocol ID
- 999997065
- Other IDs
- OH97-CH-N065
- Status last verified
- Feb 2023
- First submitted
- 19 Jun 2006
- Last updated
- 24 Feb 2023
- Results posted
- No
Publications
Kuo HC, Chang FM, Wu CH, Yao BL, Liu CH. The primary application of three-dimensional ultrasonography in obstetrics. Am J Obstet Gynecol. 1992 Mar;166(3):880-6. doi: 10.1016/0002-9378(92)91355-e.
PubMed 1550157Lee A, Deutinger J, Bernaschek G. "Voluvision": three-dimensional ultrasonography of fetal malformations. Am J Obstet Gynecol. 1994 May;170(5 Pt 1):1312-4. doi: 10.1016/s0002-9378(94)70148-2.
PubMed 8178859Steiner H, Staudach A, Spitzer D, Schaffer H. Three-dimensional ultrasound in obstetrics and gynaecology: technique, possibilities and limitations. Hum Reprod. 1994 Sep;9(9):1773-8. doi: 10.1093/oxfordjournals.humrep.a138793.
PubMed 7836537
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Anatomy by Three-Dimensional Ultrasound
- ClinicalTrials.gov ID
- NCT00340002
- Acronym / sponsor ID
- 999997065
- Conditions
- Preterm Birth, Pregnancy, Fetal Growth Abnormalities
- Keywords
- Fetal Anatomy, Pregnancy, Prenatal Diagnosis, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,650 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 26 Nov 1997
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy.
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 1,400 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography.
All cases will be placed into a digital image database. For each anomaly category, volume reconstructions will be compared to normal anatomy at specific gestational ages. Key diagnostic findings will be documented and correlated with postnatal outcome. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.
Detailed description
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy.
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 7,000 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. A subset of the fetuses enrolled in this protocol will also be examined by Magnetic Resonance Imaging (MRI) to identify potential advantages and limitations of this imaging modality when compared to 3DUS for the diagnosis of congenital anomalies. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography.
All cases will be placed into a digital image database. For each anomaly category, volume data will be acquired at specific gestational ages. Key diagnostic features will be documented and correlated with postnatal outcome. Postnatal correlative studies may include ultrasound, MRI, X-ray, computerized tomography (CT), and photography. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women aged 18 years and older |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women attending Detroit Medical Center prenatal clinics in Detroit.
Key inclusion criteria (19 listed)
- All pregnant subjects will be recruited under informed consent at either Hutzel or William Beaumont Hospitals.
- The study population for both arms of this protocol will involve pregnant women greater than or equal to 15 years.
- No fetal anomalies suspected by 2DUS.
- Excellent visualization of normal fetal anatomy by 2DUS.
- Accurate dating criteria by 1st trimester scan and/or menstrual history.
Key exclusion criteria (19 listed)
- Poor visualization of the fetus due to technical factors (e.g. obesity, surgical scar).
- History of noncompliance with prenatal visits with the current or prior pregnancy.
- Inability of the patient to fit in bore of MRI system.
- Metallic implants that would increase risk to patient.
- Previous occupational exposure to metal shop.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal Anatomy
Time frame: Ongoing
Data analysis is ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 1550157Kuo HC, Chang FM, Wu CH, Yao BL, Liu CH. The primary application of three-dimensional ultrasonography in obstetrics. Am J Obstet Gynecol. 1992 Mar;166(3):880-6. doi: 10.1016/0002-9378(92)91355-e.
- Background: PubMed 8178859Lee A, Deutinger J, Bernaschek G. "Voluvision": three-dimensional ultrasonography of fetal malformations. Am J Obstet Gynecol. 1994 May;170(5 Pt 1):1312-4. doi: 10.1016/s0002-9378(94)70148-2.
- Background: PubMed 7836537Steiner H, Staudach A, Spitzer D, Schaffer H. Three-dimensional ultrasound in obstetrics and gynaecology: technique, possibilities and limitations. Hum Reprod. 1994 Sep;9(9):1773-8. doi: 10.1093/oxfordjournals.humrep.a138793.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Romero, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Anatomy (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340002, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.